WO2006082607A1 - Medical device for two-way infusion - Google Patents

Medical device for two-way infusion Download PDF

Info

Publication number
WO2006082607A1
WO2006082607A1 PCT/IT2006/000028 IT2006000028W WO2006082607A1 WO 2006082607 A1 WO2006082607 A1 WO 2006082607A1 IT 2006000028 W IT2006000028 W IT 2006000028W WO 2006082607 A1 WO2006082607 A1 WO 2006082607A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
catheter
blood
capsule
protection
Prior art date
Application number
PCT/IT2006/000028
Other languages
French (fr)
Inventor
Antonino Cuzzucoli
Original Assignee
Medi-Line Srl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medi-Line Srl filed Critical Medi-Line Srl
Publication of WO2006082607A1 publication Critical patent/WO2006082607A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Definitions

  • the present invention concerns the medical-sanitary field and particularly relates to a device to be used for the vein and/or artery encannulation characterized by particular protection means ensuring a better safety for the operators .
  • An encannulation procedure is essentially characterized by three important steps : 1 ) insertion of the catheter of the device into the vein/artery;
  • connection of the catheter to an infusion and/or a blood sample taking system
  • the greater risks of catching infections are inherent in the second and third step, i . e . upon extracting the needle from the catheter .
  • the needle itself can easily cause a fortuitous puncture and/or leakage of blood from its cavity with consequent possible infections .
  • the channel with the catheter in situ which meanwhile is set free of the just extracted needle/spindle causes blood to flow back to the outside so that the contact with the latter is unavoidable during the connection of the catheter to the typical infusion devices (third step) .
  • the main obj ect of the present invention is to strongly reduce the fortuitous infection risk by infected blood described above .
  • Figure 1 is an exploded view of the invention, in longitudinal section;-
  • Figure 2 is a longitudinal section view similar to the previous one showing the device assembled and ready for encannulation .
  • said protection means for the cannula-needle includes a display chamber C3 of preferably plastic, transparent material with sliding self- locking, elastic tabs Al which are axially integral with the proximal end of hollow needle/spindle A2.
  • said display chamber C3 is inserted into a protection capsule A3 consisting of a cylinder body of preferably plastic, transparent material with two side recesses A4 along which both self-locking tabs Al that can be operated manually and display chamber C3 are able to slide .
  • capsule A3 is provided with self- tightening bayonet coupling means A5 able to perform a dual function : • housing a thermoplastic rubber seal A ⁇ with the purpose of incorporating the point of needle A2 when retracted, and at the same time avoiding any blood leakage; • connecting the capsule to the infusion chamber .
  • As the device is arranged to be inserted into a vein ( Fig. 2 ) display chamber C3 with tabs Al is blocked at the distal end of protection capsule A3 by suitable anchor clamps Cl , while the point of needle A2 comes out of intravenous catheter C2 and the device is thus ready for encannulation .
  • the blood reflux within display chamber C3 indicates that the vein/artery is perfectly cannulized, whereupon needle A2 is fully retracted by means of the two tabs Al until the proximal self-locking position (Fig. 1) and there clamped by suitable check clips C4.
  • the body of the needle is fully housed within protection capsule A3 and the point of the needle is incorporated within the central body A8 of seal A6, thus avoiding that the blood inside the needle/spindle comes out to the outside .
  • capsule A3 containing the needle may be removed under safety conditions by operating the self- locking bayonet coupling means A5 , leaving in situ only the infusion chamber connected to catheter C2.
  • a second peculiar feature of the present invention consists in that the main access Bl to the infusion chamber of the known devices is closed in the present invention by a plug B2 of thermoplastic material or silicone that can be pierced and is able to avoid the blood reflux to the outside .
  • the infusion chamber is provided with a side access B3 which is connected by a suitable pipe B5 to a check valve B4 with water-repellent filter which guarantees residual air within pipe B5 to be expelled and at the same time the reflux blood to be confined therein once the needle is extracted from the catheter .
  • the invention guarantees the infusion and/or blood taking operations to be carried out through said side access B3 and the relative pipe B5.
  • the connection of any connection line (phleboclysis , syringe cone, etc . ) to check valve B4 causes the valve to open automatically and to start the bi-directional flow accordingly.
  • the latter feature together with the particular protection of the needle makes the use of the device really safe .
  • the present invention has been described and illustrated according to a preferred embodiment thereof, however, it is self-evident that those skilled in the art can make technically and/or functionally equivalent modifications and/or replacements without departing from the scope of the present industrial invention .

Abstract

The present invention relates to a device for two-way infusion essentially- comprising: a catheter (C2) with a needle (A2) slidable insertable therein, protection means for the needle after the insertion of the catheter into a blood vessel, protection means against blood reflux to the outside, and an infusion chamber.

Description

Improved medical device for two-way infusion
The present invention concerns the medical-sanitary field and particularly relates to a device to be used for the vein and/or artery encannulation characterized by particular protection means ensuring a better safety for the operators .
The products which are presently on the market and used for the same purpose do not protect the medical staff and/or patients from possible infections by infected blood even if such products have reached a high degree of functionality as far as the penetration of the needle into the blood vessels and the handiness of the equipment is concerned .
An encannulation procedure is essentially characterized by three important steps : 1 ) insertion of the catheter of the device into the vein/artery;
2 ) extraction of the needle/spindle from the catheter;
3 ) connection of the catheter to an infusion and/or a blood sample taking system.
The greater risks of catching infections are inherent in the second and third step, i . e . upon extracting the needle from the catheter . In fact , during such operation ( second step) the needle itself can easily cause a fortuitous puncture and/or leakage of blood from its cavity with consequent possible infections . The channel with the catheter in situ which meanwhile is set free of the just extracted needle/spindle causes blood to flow back to the outside so that the contact with the latter is unavoidable during the connection of the catheter to the typical infusion devices (third step) .
It is then inferred that this procedure executed especially on patients for whom a diagnosis has not been made yet is potentially a high risk of infection for the medical staff .
The main obj ect of the present invention is to strongly reduce the fortuitous infection risk by infected blood described above . This has been accomplished according to the invention by providing a device for two-way infusion essentially comprising : protection means for the cannula-needle after the insertion of the catheter into the blood vessel, protection means against blood reflux to the outside, and an infusion chamber with intravenous- intraarterial catheter .
A better understanding of the invention will result from the following detailed description with reference to the accompanying drawings that show a preferred embodiments thereof only by way of a not limiting example . In the drawings :
Figure 1 is an exploded view of the invention, in longitudinal section;-
Figure 2 is a longitudinal section view similar to the previous one showing the device assembled and ready for encannulation .
With reference to the figures , said protection means for the cannula-needle according to the present invention includes a display chamber C3 of preferably plastic, transparent material with sliding self- locking, elastic tabs Al which are axially integral with the proximal end of hollow needle/spindle A2.
In the preferred embodiment disclosed said display chamber C3 is inserted into a protection capsule A3 consisting of a cylinder body of preferably plastic, transparent material with two side recesses A4 along which both self-locking tabs Al that can be operated manually and display chamber C3 are able to slide . At the distal end, capsule A3 is provided with self- tightening bayonet coupling means A5 able to perform a dual function : • housing a thermoplastic rubber seal Aβ with the purpose of incorporating the point of needle A2 when retracted, and at the same time avoiding any blood leakage; • connecting the capsule to the infusion chamber . As the device is arranged to be inserted into a vein ( Fig. 2 ) display chamber C3 with tabs Al is blocked at the distal end of protection capsule A3 by suitable anchor clamps Cl , while the point of needle A2 comes out of intravenous catheter C2 and the device is thus ready for encannulation .
The blood reflux within display chamber C3 indicates that the vein/artery is perfectly cannulized, whereupon needle A2 is fully retracted by means of the two tabs Al until the proximal self-locking position (Fig. 1) and there clamped by suitable check clips C4. Advantageously, the body of the needle is fully housed within protection capsule A3 and the point of the needle is incorporated within the central body A8 of seal A6, thus avoiding that the blood inside the needle/spindle comes out to the outside . At this point, capsule A3 containing the needle may be removed under safety conditions by operating the self- locking bayonet coupling means A5 , leaving in situ only the infusion chamber connected to catheter C2. A second peculiar feature of the present invention consists in that the main access Bl to the infusion chamber of the known devices is closed in the present invention by a plug B2 of thermoplastic material or silicone that can be pierced and is able to avoid the blood reflux to the outside . According to a further peculiar feature of the invention the infusion chamber is provided with a side access B3 which is connected by a suitable pipe B5 to a check valve B4 with water-repellent filter which guarantees residual air within pipe B5 to be expelled and at the same time the reflux blood to be confined therein once the needle is extracted from the catheter .
It is self-evident from the foregoing that the invention guarantees the infusion and/or blood taking operations to be carried out through said side access B3 and the relative pipe B5. In fact , the connection of any connection line (phleboclysis , syringe cone, etc . ) to check valve B4 causes the valve to open automatically and to start the bi-directional flow accordingly. The latter feature together with the particular protection of the needle makes the use of the device really safe . The present invention has been described and illustrated according to a preferred embodiment thereof, however, it is self-evident that those skilled in the art can make technically and/or functionally equivalent modifications and/or replacements without departing from the scope of the present industrial invention .

Claims

Claims
1. A device for intravenous encannulation or catheter- needle of the type including a catheter (C2 ) and a needle/spindle (A2 ) inserted therein, characterized in that there is provided in combination : • protection means for the cannula-needle (A2 ) after the insertion of catheter (C2 ) into the blood vessel and the following retraction of needle (A2 ) from catheter (C2 ) ;
• protection means against blood reflux to the outside; • an infusion chamber with intravenous-intraarterial catheter (C2 ) .
2. The device according to the preceding claim, characterized in that said protection means for the cannula-needle (A2 ) after its retraction from catheter (C2 ) can be removed.
3. The device according to claim 1 , characterized in that said protection means for the cannula-needle (A2 ) includes a display chamber (C3 ) of transparent material with sliding self-locking, elastic tabs (Al) , said display chamber and said tabs being axially integral with the proximal end of hollow needle/spindle (A2 ) .
4. The device according to the preceding claim, characterized in that said display chamber (C3 ) is inserted into a protection capsule (A3 ) consisting of a cylinder body of preferably plastic, transparent material with two side recesses (A4 ) along which both self-locking tabs (Al) that can be operated manually are able to slide .
5. The device according to the preceding claim, characterized in that the distal end of capsule (A3 ) is provided with self-tightening bayonet coupling means (A5 ) .
6. The device according to the preceding claim, characterized in that said bayonet coupling means (A5 ) are capable of :
• housing a thermoplastic rubber seal (Aβ) with the purpose of incorporating the point of needle (A2 ) when retracted, and at the same time avoiding any blood leakage from the cavity of the needle/spindle;
• connecting capsule (A3) to the infusion chamber .
7. The device according to the preceding claim, characterized in that as the device is arranged to be inserted into a vein for encannulation, display chamber (C3 ) with tabs (Al ) is able to be blocked at the distal end of protection capsule (A3 ) by suitable anchor clamps (Cl ) , while the point of needle (A2 ) comes out of intravenous catheter (C2 ) .
8. The device according to the preceding claim, characterized in that as the blood reflux to display chamber (C3) indicates that the vein/artery is perfectly cannulized, needle (A2 ) is able to be fully retracted by means of the two tabs (Al ) until a proximal self-locking position .
9. The device according to the preceding claim, characterized in that there are provided suitable check clips (C4 ) able to block the fully extracted needle, thus providing that the body of the needle is fully housed inside protection capsule (A3 ) and the point of the needle is incorporated within the central body (A8 ) of seal (Aβ) , thus avoiding that the blood inside the needle/spindle comes out to the outside .
10. The device according to the preceding claim, characterized in that capsule (A3) containing the needle may be removed by operating the self-locking bayonet coupling means (A5) , leaving in situ only the infusion chamber connected to catheter (C2 ) .
11. The device according to claim 1 , characterized in that said infusion chamber is closed by a plug (B2 ) of thermoplastic material or silicone that can be pierced and is able to avoid the blood reflux to the outside .
12. The device according to any preceding claim, characterized in that said infusion chamber is provided with a side access (B3 ) which is connected by a suitable pipe (B5 ) to a check valve (B4 ) with water- repellent filter which guarantees residual air within pipe (B5 ) to be expelled and at the same time the reflux blood to be confined therein once needle (A2 ) is extracted from catheter (C2 ) .
13. The device according to claim 4 , characterized in that said display chamber (C3 ) and said protection capsule (A3) are of plastic material .
14. A device for intravenous encannulation as essentially described and illustrated in the present description and the accompanying drawings .
PCT/IT2006/000028 2005-02-03 2006-01-18 Medical device for two-way infusion WO2006082607A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITRC20050001 ITRC20050001A1 (en) 2005-02-03 2005-02-03 MEDICAL DEVICE FOR DOUBLE INFUSION VIA A "CLOSED SYSTEM"
ITRC2005A000001 2005-02-03

Publications (1)

Publication Number Publication Date
WO2006082607A1 true WO2006082607A1 (en) 2006-08-10

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT2006/000028 WO2006082607A1 (en) 2005-02-03 2006-01-18 Medical device for two-way infusion

Country Status (2)

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IT (1) ITRC20050001A1 (en)
WO (1) WO2006082607A1 (en)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2044970A1 (en) 2007-10-04 2009-04-08 Medi-Line Srl Closed system safety device for venous and arterial cannulation
WO2011038931A1 (en) * 2009-10-01 2011-04-07 B. Braun Melsungen Ag Catheter insertion device
WO2012031145A1 (en) * 2010-09-01 2012-03-08 Becton, Dickinson And Company Neonatal and pediatric catheter system
CN103878657A (en) * 2013-12-27 2014-06-25 力天模塑(大连)有限公司 Medical indwelling needle chamfering machine
USD808013S1 (en) 2016-10-27 2018-01-16 Smiths Medical Asd, Inc. Catheter
US10675440B2 (en) 2016-02-18 2020-06-09 Smiths Medical Asd, Inc. Closed system catheter
CN114616014A (en) * 2019-10-28 2022-06-10 麦迪.普罗有限责任公司 Biomedical device for arterial access
WO2023191233A1 (en) * 2022-03-31 2023-10-05 (주)카이로스 Needle holder

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4966586A (en) * 1987-09-04 1990-10-30 Vaillancourt Vincent L Closed system over-the-needle I.V. catheter
WO1997045151A1 (en) * 1996-05-30 1997-12-04 Cuppy Michael J Catheter system
US5911705A (en) * 1996-04-04 1999-06-15 Becton Dickinson And Company One step catheter advancement automatic needle retraction system
US5954698A (en) * 1997-01-08 1999-09-21 Vadus, Inc. Catheter apparatus having valved catheter hub and needle protector
WO2000056388A2 (en) * 1999-03-19 2000-09-28 Anglo Operations Limited Intravenous catheter insertion assembly
US6213978B1 (en) * 1998-10-27 2001-04-10 Cherie A. Voyten Intravenous catheter insertion apparatus

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4966586A (en) * 1987-09-04 1990-10-30 Vaillancourt Vincent L Closed system over-the-needle I.V. catheter
US5911705A (en) * 1996-04-04 1999-06-15 Becton Dickinson And Company One step catheter advancement automatic needle retraction system
WO1997045151A1 (en) * 1996-05-30 1997-12-04 Cuppy Michael J Catheter system
US5954698A (en) * 1997-01-08 1999-09-21 Vadus, Inc. Catheter apparatus having valved catheter hub and needle protector
US6213978B1 (en) * 1998-10-27 2001-04-10 Cherie A. Voyten Intravenous catheter insertion apparatus
WO2000056388A2 (en) * 1999-03-19 2000-09-28 Anglo Operations Limited Intravenous catheter insertion assembly

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2044970A1 (en) 2007-10-04 2009-04-08 Medi-Line Srl Closed system safety device for venous and arterial cannulation
US8932257B2 (en) 2009-10-01 2015-01-13 B. Braun Melsungen Ag Catheter insertion device
WO2011038931A1 (en) * 2009-10-01 2011-04-07 B. Braun Melsungen Ag Catheter insertion device
EP3485932A1 (en) * 2009-10-01 2019-05-22 B. Braun Melsungen AG Catheter insertion device
CN102548604A (en) * 2009-10-01 2012-07-04 B.布劳恩梅尔松根股份公司 Catheter insertion device
US9320870B2 (en) 2009-10-01 2016-04-26 B. Braun Melsungen Ag Catheter insertion device
US9375551B2 (en) 2010-09-01 2016-06-28 Becton, Dickinson And Company Neonatal and pediatric catheter system
CN103153383A (en) * 2010-09-01 2013-06-12 贝克顿·迪金森公司 Neonatal and pediatric catheter system
WO2012031145A1 (en) * 2010-09-01 2012-03-08 Becton, Dickinson And Company Neonatal and pediatric catheter system
CN103878657A (en) * 2013-12-27 2014-06-25 力天模塑(大连)有限公司 Medical indwelling needle chamfering machine
US10675440B2 (en) 2016-02-18 2020-06-09 Smiths Medical Asd, Inc. Closed system catheter
USD808013S1 (en) 2016-10-27 2018-01-16 Smiths Medical Asd, Inc. Catheter
USD893711S1 (en) 2016-10-27 2020-08-18 Smiths Medical Asd, Inc. Catheter assembly
CN114616014A (en) * 2019-10-28 2022-06-10 麦迪.普罗有限责任公司 Biomedical device for arterial access
CN114616014B (en) * 2019-10-28 2023-11-14 麦迪.普罗有限责任公司 Biomedical devices for arterial access
WO2023191233A1 (en) * 2022-03-31 2023-10-05 (주)카이로스 Needle holder

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